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Deep Brain Stimulation for Traumatic Brain Injury

This study is currently recruiting participants.
Verified May 2013 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01277952
First received: January 13, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes

January 13, 2011
May 14, 2013
January 2011
December 2014   (final data collection date for primary outcome measure)
Improvement in Brain Functioning [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
Brain functioning improvement in functional independence, community participation and subjective well-being.
Same as current
Complete list of historical versions of study NCT01277952 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Deep Brain Stimulation for Traumatic Brain Injury
Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury

The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury.

The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury. DBS has been proven safe and efficacious for remediation of multiple neurological conditions. It is the hope of the study team that the protocol will provide further insight into the potential of DBS to improve the quality of life and functioning of persons with severe disability due to TBI and at the same time can provide new clinical insights that will improve treatment for the entire spectrum of injury severity.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Traumatic Brain Injury
Device: Deep Brain Stimulation
Brain pace maker, implanted in the brain
Other Name: DBS
Experimental: DBS Surgery
Deep brain stimulation (DBS) will be the treatment option in this study along with behavioral interventions for participants with severe disability due to Traumatic Brain Injury (TBI) 24 months post their injury, the participants will have severe disabilities in behavioral and emotional self-regulation, cognitive impairments and somatic symptoms.
Intervention: Device: Deep Brain Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 24 months post traumatic brain injury Scores in Severe range of the Glasgow Outcome Scale-Extended Evidence of impaired cognitive functioning Medically and neurologically stable

Exclusion Criteria:

  • Medical contraindications for surgery Evidence of substance abuse in the last 12 months Current Diagnosis of major depressive disorder current participation in rehabilitation services Co-morbid conditions that would interfere with study activities
Both
20 Years to 60 Years
No
Contact: Phuong Nguyen 6143666952 phuong.nguyen2@osumc.edu
United States
 
NCT01277952
2010H0264
Yes
Ali Rezai, MD, The Ohio State University
Ali Rezai, MD
Not Provided
Principal Investigator: Ali Rezai, M.D. Ohio State University
Ohio State University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP